Covid-19 Living Data

Trial NCT04447534
Publication Abd-Elsalam S, Biol Trace Elem Res, 2020 (published paper)
Dates: 2020-06-23 to 2020-08-23
Funding:
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Egypt Follow-up duration (days): 28
Inclusion criteria	Patients with with a confirmed diagnosis of COVID-19 infection by real-time PCR test
Exclusion criteria	Report: Patient with hypokalemia or hypomagnesemia, porphyria, neutrophilia, myasthenia gravis, maculopathy or changes in the visual field, heart failure, prolonged QT interval in ECG, liver cirrhosis, psoriasis, epilepsy, anemia from pyruvate kinase and G6PD deficiencies, chronic kidney disease, and pregnant or lactating females. Registry: Contraindications or hypersensitivity to chloroquine
Interventions
	Treatment Hydroxychloroquine+Zinc
	Control Hydroxychloroquine (200 mg)
Participants
	Randomized 191 participants (n₁=96 / n₂= 95)
	Characteristics of participants N=191 Mean age : 43.6 116 males Severity : Mild: n=21 / Moderate: n=113/ Severe: n=38 Critical: n=19
Primary outcome
	In the register Number of patients with improvement or mortality [ Time Frame: 2 weeks ]
	In the report Recovery within 28 days, need for mechanical ventilation, and death.
Documents available	Protocol NR Statistical plan NR Data-sharing stated No
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The registry indicates that the trial was randomized and double blinded (participant and care provider) but no details are provided in the report on the measures were taken to establish and maintain blinding such as a placebo for zinc in the control group. There is no change from the trial registration in the intervention and control treatments however doses and frequency were not reported in the trial registration. There were some differences between exclusion criteria and follow up duration between the trial registry and the published article.